title: Use of decongestants during pregnancy and the risk of birth defects.
abstract: Previous studies suggested that early pregnancy exposure to specific oral decongestants increases the risks of several birth defects. Using January 1993-January 2010 data from the Slone Epidemiology Center Birth Defects Study, we tested those hypotheses among 12,734 infants with malformations (cases) and 7,606 nonmalformed control infants in the United States and Canada. Adjusted odds ratios and 95% confidence intervals were estimated for specific birth defects, with controlling for potential confounders. Findings did not replicate several hypotheses but did support 3 previously reported associations: phenylephrine and endocardial cushion defect (odds ratio = 8.0; 95% confidence interval: 2.5, 25.3; 4 exposed cases), phenylpropanolamine and ear defects (odds ratio = 7.8; 95% confidence interval: 2.2, 27.2; 4 exposed cases), and phenylpropanolamine and pyloric stenosis (odds ratio = 3.2; 95% confidence interval: 1.1, 8.8; 6 exposed cases). Hypothesis-generating analyses involving multiple comparisons identified a small number of associations with oral and intranasal decongestants. Accumulating evidence supports associations between first-trimester use of specific oral and possibly intranasal decongestants and the risk of some infrequent specific birth defects.
authors.affiliation: Department of Epidemiology, Harvard School of Public Health, Harvard University, Boston, MA, USA.
authors.forename: Wai-Ping
authors.initials: WP
authors.lastname: Yau
authors.forename: Allen A
authors.initials: AA
authors.lastname: Mitchell
authors.forename: Kueiyu Joshua
authors.initials: KJ
authors.lastname: Lin
authors.forename: Martha M
authors.initials: MM
authors.lastname: Werler
authors.forename: Sonia
authors.initials: S
authors.lastname: Hernández-Díaz
mesh_terms: D000014:Abnormalities, Drug-Induced; D000281:Administration, Intranasal; D000284:Administration, Oral; D000328:Adult; D002170:Canada; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D016015:Logistic Models; D014663:Nasal Decongestants / Q000008:administration & dosage / Q000009:adverse effects*; D004366:Nonprescription Drugs / Q000008:administration & dosage / Q000009:adverse effects*; D016017:Odds Ratio; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D057566:Self Report; D014481:United States
chemical_list: D014663:Nasal Decongestants; D004366:Nonprescription Drugs
keywords: birth defects; decongestants; maternal exposure; pregnancy